Title

Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
A Prospective, Bi-centric,Randomized, Primary Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    63
The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.
Study Started
May 31
2011
Primary Completion
Aug 26
2015
Study Completion
Aug 26
2015
Last Update
Jun 08
2017

Drug Aclasta

1 x intravenous non-current drip (infusion)

Drug Placebo

NaCl Solution

Aclasta Active Comparator

NaCl Solution Placebo Comparator

Criteria

Inclusion Criteria:

Men: age over ≥ 18 years or women: age over ≥ 18 years with finished reproductivity according to the following definition:
≥ 12 month persistent natural (spontaneous) amenorrhoea (women aged <50: additionally: FSH >40MIE/ml and estrogen deficiency of <30pg/ml or a negative estrogen test)
status post hysterectomy and / or bilateral oophorectomy
finished reproduction planning
secure diagnosis of bone marrow edema using MRT
current osteologic basic laboratory values (≤ 4 weeks before V2) according to DVO criteria
presence of an personally signed informed consent for the participation in the study

Exclusion Criteria:

- subchondral bone loss or already occurred cartilage damage due to the bone marrow edema
reactive bone marrow edema with advanced arthrotic changes in the adjacent joint (grade III and IV according to Kellgren and Lawrence)
patients with edematous changes in bone marrow due to the diagnosis of M. Sudeck / algodystrophy / Complex Regional Pain Syndrome (CRPS)
patients with known hypo- and hyperparathyroidism, osteogenesis imperfecta, osteomalacia, M. Paget or another systemic skeletal diseases, except osteoporosis
patients with bone necrosis in the painful skeletal region
patients with infectious process at the affected bone or the adjacent joint and adjacent soft parts, respectively
patients with diagnosed or assumed rheumatoid arthritis, Lupus erythematodes, collagenosis or vasculitides

patients with advanced renal insufficiency (GFR according to Cockcroft

/ Gault ≤ 40 ml/min/KO)

patients with malignant diseases with osseous manifestation in anamnesis/history
status post malignant basic/primary disease with large dosed chemotherapy
current or massive dose therapy completed before less than 6 weeks (>7.5mg prednisolon equivalent) with glucocorticoids
patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis
vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia
etiological vague/ambiguous AP-increase
symptomatic renal calculus or nephrocalcinosis within 2 years before V2
recent fracture within the last 3 months independent of the localisation
non consolidated fractures
previous treatment with i.v. bisphosphonates within the last 12 months
previous treatment with oral bisphosphonates within the last 12 months and longer than 3 months
pre-treatment with prostacyclin analogs (Ilomedin® / Iloprost®) within the past 6 months
Current treatment due to inflammatory diseases of the jaw area as well as planned tooth extractions or tooth extractions less than 6 months ago or oral surgery implant treatment
pregnancy or nursing period
patients immediately involved in the conduction of the trial and relatives
patients with current proceedings related to the bone marrow edema
patients for which the participation in the study carries an increased risk under consideration of the health condition due to the assessment of the investigator
participation in another clinical trial within 30 days before study start or during the trial
participation of patient who might be dependent on the investigator, also the spouse, parents or children
No Results Posted